Venous ThromboembolismPhase 2VTENCT04041843
Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism
A Phase 2 study testing Apixaban in people with Venous Thromboembolism, run by New York Medical College at 1 site in United States.
Trial summary
Patients who have developed a venous thrombosis will receive apixaban to treat and prevent a secondary thromboembolism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Apixaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2017to 31 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children and adolescents with a newly diagnosed primary VTE.
- Treatment with apixaban has to begin within 72 hours of the diagnosis of VTE.
- Patients who have received heparin at the beginning of their diagnosis and are willing to switch to apixaban, are allowed to do so within 72 hours of their treatment. Patients who are switched to apixaban are not allowed to receive any other systemic anticoagulant therapy.
- VTE confirmed by diagnostic imaging.
- Children with body weight of ≥ 40 kg and are able to tolerate medication by mouth or administered via an NG or GT tube.
- Adequate liver function: AST and/or ALT <5 times ULN, and/or Direct bilirubin <2 times ULN
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- Platelet count of at least ≥ 30,000/ul.
- Adequate renal function: >30% of GFR for age
- Female subjects of childbearing potential must not be nursing or pregnant with negative urine pregnancy test within 72 hours prior to dosing with study medication.
- Signed written informed consent
Who cannot join
- Current or recent (within 3 months) apixaban administration.
- Patient is unable to tolerate medications by oral route or by n/g administration, peptic ulcer disease, intestinal obstruction, toxic megacolon, typhlitis, or short gut syndrome.
- History of primary bleeding disorder and first degree family history of bleeding disorder.
- Active bleeding or high risk of bleeding at the time of study entry.
- History of significant head injury and/or any history of intracranial hemorrhage.
- Conditions predispose to intracranial bleed; e.g. brain tumor, brain metastasis.
- Uncontrolled Grade 3 or 4 severe hypertension.
- History of allergy to apixaban or factor Xa inhibitors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of an Oral Anticoagulant "Apixaban" for theTreatment of Venous Thromboembolism in Children and Adolescents
Patients who have developed a venous thrombosis will receive apixaban to treat and prevent a secondary thromboembolism.
- Conditions
- Venous Thromboembolism
- Being tested
- Apixaban
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
Apixaban 10 mg twice daily p.o. for seven days followed by 5 mg twice daily p.o. for children and adolescents weighting ≥40 kg
| Study group | Role | What they receive |
|---|---|---|
| Abixaban | Experimental | Apixaban 10 mg twice daily p.o. for seven days followed by 5 mg twice daily p.o. for children and adolescents weighting ≥40 kg who have been diagnosed with a thrombosis. Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
venous thromboembolism (VTE) formation
No new VTE
Measured: 7-90 days
Secondary outcomes (1)
Doppler ultrasound vein imaging
Change in VTE on Doppler ultrasound
Measured: day 8-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start2 Jun 2017
- Primary completion31 May 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oya Tugal, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041843
- Sponsor's protocol ID
- NYMC 191
- Acronym
- VTE
- Status last verified
- Oct 2022
- First submitted
- 31 Jul 2019
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of an Oral Anticoagulant "Apixaban" for theTreatment of Venous Thromboembolism in Children and Adolescents
- ClinicalTrials.gov ID
- NCT04041843
- Acronym / sponsor ID
- VTE / NYMC 191
- Conditions
- Venous Thromboembolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who have developed a venous thrombosis will receive apixaban to treat and prevent a secondary thromboembolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abixaban | Experimental | Drug: ApixabanApixaban 10 mg twice daily p.o. for seven days followed by 5 mg twice daily p.o. for children and adolescents weighting ≥40 kg who have been diagnosed with a thrombosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Children and adolescents with a newly diagnosed primary VTE.
- Treatment with apixaban has to begin within 72 hours of the diagnosis of VTE.
- Patients who have received heparin at the beginning of their diagnosis and are willing to switch to apixaban, are allowed to do so within 72 hours of their treatment. Patients who are switched to apixaban are not allowed to receive any other systemic anticoagulant therapy.
- VTE confirmed by diagnostic imaging.
- Children with body weight of ≥ 40 kg and are able to tolerate medication by mouth or administered via an NG or GT tube.
Key exclusion criteria (8 listed)
- Current or recent (within 3 months) apixaban administration.
- Patient is unable to tolerate medications by oral route or by n/g administration, peptic ulcer disease, intestinal obstruction, toxic megacolon, typhlitis, or short gut syndrome.
- History of primary bleeding disorder and first degree family history of bleeding disorder.
- Active bleeding or high risk of bleeding at the time of study entry.
- History of significant head injury and/or any history of intracranial hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: EliquisApixaban 10 mg twice daily p.o. for seven days followed by 5 mg twice daily p.o. for children and adolescents weighting ≥40 kg | Drug | Abixaban |
Primary outcome
venous thromboembolism (VTE) formation
Time frame: 7-90 days
No new VTE
1 secondary outcome
Doppler ultrasound vein imaging
Time frame: day 8-15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oya Tugal, MD principal investigator
New York Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apixaban in people with Venous Thromboembolism, run by New York Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
venous thromboembolism (VTE) formation (time frame: 7-90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.